Phase 2 Study of ELV001 Added to Methotrexate and TNF Inhibitor for Active Rheumatoid Arthritis with Inadequate Response

What this Trial Is About

Researchers are evaluating the safety and effectiveness of different doses of ELV001 in adults with active rheumatoid arthritis who have not responded adequately to methotrexate and tumor necrosis factor inhibitors. This Phase 2 randomized, double-blind, placebo-controlled study plans to enroll about 180 to 220 participants and lasts 32 weeks from screening to the end of the study. The study aims to understand how ELV001 affects disease activity scores and other health measures in this patient group. Participants are divided into four groups receiving either placebo or ELV001 at doses of 25 mg, 75 mg, or 125 mg. The study includes a 4-week screening period, followed by a 12-week placebo-controlled treatment phase. After week 12, all participants receive ELV001 at 75 mg or 125 mg doses during a treatment extension lasting until week 24. This is followed by a 4-week safety follow-up period to monitor participants. Throughout the study, participants will have regular assessments including disease activity scoring, joint counts, health questionnaires, blood tests, ECGs, and vital sign monitoring up to week 28. The main measurement is the change in disease activity score from baseline to week 12. Safety outcomes such as adverse events and laboratory results will be tracked up to 32 weeks. Participants will be closely monitored for response and side effects during the entire 32-week study duration.

A Study to Assess the Safety and Efficacy of Different Doses of ELV001 to Treat Active Rheumatoid Arthritis in Patients With an Inadequate Response to Methotrexate and Tumor Necrosis Factor Inhibition (START SYNERGY)